An observational study in Venous Thrombosis Deep (Limbs) and Venous Thrombosis, sponsored by FlowPhysix, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by FlowPhysix, Inc. · Observational
The objective of this study is to evaluate how well and how safe the FLOWRUNNER Aspiration System works for treating blood clots in the arms or legs in real-life medical settings.
The study is a registry to collect data from standard of care mechanical thrombectomy procedure using FLOWRUNNER Aspiration System. The FLOWRUNNER Aspiration System is a single use catheter based system indicated for the removal of fresh, soft emboli (a soft clot) and thrombi (a stationary clot) from vessels of the peripheral (in the arms and legs) and venous (blood vessels responsible for carrying deoxygenated blood back to your heart and lungs) system.
Adults (≥ 18 years) undergoing venous thrombectomy with the FLOWRUNNER Aspiration System for acute or sub-acute symptomatic upper- or lower-extremity venous thrombosis.
Eligibility Criteria:
Exclusion Criteria:
High-risk for pulmonary embolism (PE), defined as those presenting with:
Any prior or current cancer diagnosis that, in the investigator's judgment, would pose an unacceptable risk or confound study outcomes including but not limited to:
Known antiphospholipid syndrome or other high-risk coagulation disorders, including:
Chronic non-ambulatory status, defined as:
Contraindicated for intravascular therapy including:
Any condition that, in the investigator's judgment, would pose unacceptable risk or interfere with study participation, including:
The study is an observational registry to collect data on the standard of care treatment of venous thrombosis. There is no investigational intervention. All participants will receive mechanical thrombectomy as standard of care.
Other: Mechanical Thrombectomy - Standard of Care procedure for venous thrombosis
Participant will receive mechanical thrombectomy for venous thrombosis as standard of care. This study is an observational registry to collect data on the standard of care non investigational intervention.
Procedure Success
The number of patients that had a response to treatment after the standard of care mechanical thrombectomy procedure with the study device, defined as removal of thrombus (a large amount of the blood clot from the vein or artery) during the study procedure.
Time frame: Immediately Post Procedure
Safety Events will measure any risks that may occur during or after the study procedure
The number of patients that have serious problems after the standard of care mechanical thrombectomy procedure that could be life threatening or cause major harm.
Time frame: Within 30 days of the study procedure
Procedure Results
The number of patients that have restoration of flow in the treated vein as measured by X-ray.
Time frame: Immediately after the study procedure
Vein Patency
The number of patients that have vein patency as measured by duplex ultrasound or other imaging.
Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.
Vein Disability Score
The number of patients that have improvement in Vein Disability Score which is a clinical assessment by the physician to score how chronic venous disease affects a patient's mobility and daily functionality. A score of 0 means no symptoms and a score of 3 means severe disability. The total score per follow up visit will be compared to baseline.
Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure
Villalta Score
The number of patients that have improvement in Villalta Score which is a clinical assessment by the physician to score patient reported symptoms from a score of 0 to 3 based on severity. A score of 0 indicates absence of symptoms and a score of 3 indicates severe symptoms. The total score is the sum of all individual scores. 0-4 is no symptoms to \>15 is severe symptoms. Clinical signs will be scored by the physician or nurse after physical examination of the affected arm/leg.
Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure
Quality of Life
The number of patients that have an improvement of Quality of Life as measured by the EuroQol Questionnaire. It evaluates 5 dimensions of health, with 5 levels of severity for each. A score of 1 for each question is good health, a score of 5 for each question is poor health.
Time frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.
Additional Safety Events
The number of patients that have serious adverse events (SAEs) will be evaluated.
Time frame: Up to 24 months after the study procedure
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.